System and method for hyoidplasty

ABSTRACT

Methods and devices are disclosed for manipulating the hyoid bone, such as to treat obstructive sleep apnea. An implant is positioned adjacent a hyoid bone. The spatial orientation of the hyoid bone is manipulated, to affect the configuration of the airway. The implant restrains the hyoid bone in the manipulated configuration. The implant is positioned adjacent to pharyngeal structures to dilate the pharyngeal airway and/or to support the pharyngeal wall against collapse.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to a system and method for treatingupper airway obstruction, sleep disordered breathing, upper airwayresistance syndrome and snoring.

2. Description of the Related Art

Respiratory disorders during sleep are recognized as a common disorderwith significant clinical consequences. During the various stages ofsleep, the human body exhibits different patterns of brain and muscleactivity. In particular, the REM sleep stage is associated with reducedor irregular ventilatory responses to chemical and mechanical stimuliand a significant degree of muscle inhibition. This muscle inhibitionmay lead to relaxation of certain muscle groups, including but notlimited to muscles that maintain the patency of the upper airways, andcreate a risk of airway obstruction during sleep. Because musclerelaxation narrows the lumen of the airway, greater inspiratory effortmay be required to overcome airway resistance. This increasedinspiratory effort paradoxically increases the degree of airwayresistance and obstruction through a Bernoulli effect on the flaccidpharyngeal walls during REM sleep.

Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2to 4% of the population in the United States. OSA is characterized by anintermittent cessation of airflow in the presence of continuedinspiratory effort. When these obstructive episodes occur, an affectedperson will transiently arouse, regain muscle tone and reopen theairway. Because these arousal episodes typically occur 10 to 60 timesper night, sleep fragmentation occurs which produces excessive daytimesleepiness. Some patients with OSA experience over 100 transient arousalepisodes per night.

In addition to sleep disruption, OSA may also lead to cardiovascular andpulmonary disease. Apnea episodes of 60 seconds or more have been shownto decrease the partial pressure of oxygen in the lung alveoli by asmuch as 35 to 50 mm Hg. Some studies suggest that increasedcatecholamine release in the body due to the low oxygen saturationcauses increases in systemic arterial blood pressure, which in turn cancauses left ventricular hypertrophy and eventually left heart failure.OSA is also associated with pulmonary hypertension, which can result inright heart failure.

Radiographic studies have shown that the site of obstruction in OSA isisolated generally to the supralaryngeal airway, but the particular siteof obstruction varies with each person and multiple sites may beinvolved. A small percentage of patients with OSA have obstructions inthe nasopharynx caused by deviated septums or enlarged turbinates. Theseobstructions may be treated with septoplasty or turbinate reductionprocedures, respectively. More commonly, the oropharynx and thehypopharynx are implicated as sites of obstruction in OSA. Some studieshave reported that the occlusion begins with the tongue falling back inan anterior-posterior direction (A-P) to contact with the soft palateand posterior pharyngeal wall, followed by further occlusion of thelower pharyngeal airway in the hypopharynx. This etiology is consistentwith the physical findings associated with OSA, including a large baseof tongue, a large soft palate, shallow palatal arch and a narrowmandibular arch. Other studies, however, have suggested that increasedcompliance of the lateral walls of the pharynx contributes to airwaycollapse. In the hypopharynx, radiographic studies have reported thathypopharyngeal collapse is frequently caused by lateral narrowing of thepharyngeal airway, rather an narrowing in the A-P direction.

OSA is generally diagnosed by performing overnight polysomnography in asleep laboratory. Polysomnography typically includeselectroencephalography to measure the stages of sleep, anelectro-oculogram to measure rapid eye movements, monitoring ofrespiratory effort through intercostal electromyography or piezoelectricbelts, electrocardiograms to monitor for arrhythmias and measurement ofnasal or oral airflow and pulse oximetry to measure to measure oxygensaturation of the blood.

Following the diagnosis of OSA, some patients are prescribed weight lossprograms as part of their treatment plan, because of the associationbetween obesity and OSA. Weight loss may reduce the frequency of apneain some patients, but weight loss and other behavioral changes aredifficult to achieve and maintain. Therefore, other modalities have alsobeen used in the treatment of OSA, including pharmaceuticals,non-invasive devices and surgery.

Among the pharmaceutical treatments, respiratory stimulants and drugsthat reduce REM sleep have been tried in OSA. Progesterone, theophyllineand acetozolamide have been used as respiratory stimulants, but eachdrug is associated with significant side effects and their efficacy inOSA is not well studied. Protriptyline, a tricyclic antidepressant thatreduces the amount of REM sleep, has been shown to decrease thefrequency of apnea episodes in severe OSA, but is associated withanti-cholinergic side effects such as impotence, dry mouth, urinaryretention and constipation.

Other modalities are directed at maintaining airway patency duringsleep. Oral appliances aimed at changing the position of the softpalate, jaw or tongue are available, but patient discomfort and lowcompliance have limited their use. Continuous Positive Airway Pressure(CPAP) devices are often used as first-line treatments for OSA. Thesedevices use a sealed mask which produce airflow at pressures of 5 to 15cm of water and act to maintain positive air pressure within thepharyngeal airway and thereby maintain airway patency. Although CPAP iseffective in treating OSA, patient compliance with these devices are lowfor several reasons. Sleeping with a sealed nasal mask is uncomfortablefor patients. Smaller sealed nasal masks may be more comfortable topatients but are ineffective is patients who sleep with their mouthsopen, as the air pressure will enter the nasopharynx and then exit theoropharynx. CPAP also causes dry nasal passages and congestion.

Surgical treatments for OSA avoid issues with patient compliance and areuseful for patients who fail conservative treatment. One surgery usedfor OSA is uvulopalatopharyngoplasty (UPPP). UPPP attempts to improveairway patency in the oropharynx by eliminating the structures thatcontact the tongue during sleep. This surgery involves removal of theuvula and a portion of the soft palate, along with the tonsils andportions of the tonsillar pillars. Although snoring is reduced in amajority of patients who undergo UPPP, the percentage of patients whoexperience reduced frequency of apnea episodes or improved oxygensaturation is substantially lower. Postoperatively, many patients thathave undergone UPPP continue to exhibit oropharyngeal obstruction orconcomitant hypopharyngeal obstruction. Nonresponders often havephysical findings of a large base of tongue, an omega-shaped epiglottisand redundant aryepiglottic folds. UPPP is not a treatment directed atthese structures. UPPP also exposes patients to the risks of generalanesthesia and postoperative swelling of the airway that will require atracheostomy. Excessive tissue removal may also cause regurgitation offood and liquids into the nasopharynx.

Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar procedureto UPPP that uses a CO2 laser to remove the uvula and portions of thesoft palate, but the tonsils and the lateral pharyngeal walls are notremoved.

For patients who fail UPPP or LAUP, other surgical treatments areavailable but these surgeries entail significantly higher risks ofmorbidity and mortality. In genioglossal advancement with hyoid myotomy(GAHM), an antero-inferior portion of the mandible; which includes theattachment of the attachment point of the tongue musculature, isrepositioned forward and in theory will pull the tongue forward andincrease airway diameter. The muscles attached to the inferior hyoidbone are severed to allow the hyoid bone to move superiorly andanteriorly. Repositioning of the hyoid bone expands the retrolingualairspace by advancing the epiglottis and tongue base anteriorly. Thehyoid bone is held in its new position by attaching to the mandibleusing fascia. Variants of this procedure attach the hyoid boneinferiorly to the thyroid cartilage.

A laser midline glossectomy (LMG) has also been tried in some patientswho have failed UPPP and who exhibit hypopharyngeal collapse onradiographic studies. In this surgery, a laser is used to resect themidline portion of the base of the tongue. This involves significantmorbidity and has shown only limited effectiveness.

In some patients with craniofacial abnormalities that include a recedingmandible, mandibular or maxillomandibular advancement surgeries may beindicated for treatment of OSA. These patients are predisposed to OSAbecause the posterior mandible position produces posterior tonguedisplacement that causes airway obstruction. In a mandibular advancementprocedure, the mandible is cut bilaterally posterior to the last molarand advanced forward approximately 10 to 14 mm. Bone grafts are used tobridge the bone gap and the newly positioned mandible is wire fixated tothe maxilla until healing occurs. Mandibular advancement may be combinedwith a Le Fort I maxillary osteotomy procedure to correct associateddental or facial abnormalities. These procedures have a high morbidityand are indicated only in refractory cases of OSA.

Experimental procedures described in the clinical literature for OSAinclude the volumetric radiofrequency tissue ablation and hyoidplasty,where the hyoid bone is cut into several segments and attached to abrace that widens the angle of the U-shaped hyoid bone. The latterprocedure has been used in dogs to increase the pharyngeal airway lumenat the level of the hyoid bone. The canine hyoid bone, however, isunlike a human hyoid bone because the canine hyoid bone comprises nineseparate and jointed bones, while the human hyoid bone is typically asingle bone or cartilage.

Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating obstructive sleep apnea.

SUMMARY OF THE INVENTION

There is provided in accordance with one aspect of the presentinvention, a method of performing hyoidplasty. The method comprises thesteps of accessing a hyoid bone, having a first and a second greaterhorn spaced apart by a first distance. The space between the first andsecond greater horns is increased to a second distance, and the firstand second greater horns are restrained at the second distance. Thehyoid bone accessed may be a human hyoid bone.

In one implementation of the invention, the accessing step isaccomplished in a minimally invasive procedure.

The increasing the space step may comprise flexing the hyoid bone,separating the hyoid bone into at least two components, or separatingthe hyoid bone into at least three components. The second distance maybe at least about 110%, in some procedures at least about 120% and inother procedures at least about 130% of the first distance. Therestraining step may comprise securing the hyoid bone to a hyoid bonesupport. Alternatively, the restraining step may occur without attachingan implant to the hyoid bone.

In accordance with another aspect of the present invention, there isprovided an implant for attachment to a hyoid bone. The implantcomprises an implant body, having a first attachment zone configured forattachment to a first portion of a hyoid bone. The implant body includesa second attachment zone, configured for attachment to a second portionof a hyoid bone. A connection is provided between the first and secondattachment zones, which allows movement of the first and secondattachment zones with respect to each other. A lock may be carried bythe body, for fixing the relationship between the first and secondattachment zones.

The connection may comprise a flexible portion of the body.Alternatively, the connection may comprise a hinge, pivot or a flexibleelement carried by the body. The lock may comprise a threaded shaft, orany of a variety of interference fit structures.

In accordance with a further aspect of the present invention, there isprovided a method of treating a patient. The method comprises the stepsof providing a hyoid bone support, having a first arm and a second armwhich are transformable from a moveable relationship with respect toeach other to a fixed relationship with respect to each other. The firstarm is attached to a first part of a hyoid bone. The second arm isattached to a second part of a hyoid bone. The configuration of thehyoid bone is changed, and the support is secured in the fixedrelationship.

The changing the configuration step may comprise increasing a lateraldistance between the first and second parts of the hyoid bone, and/orincreasing an anterior-posterior distance between the first and secondparts of the hyoid bone. Increasing the anterior-posterior distance maycomprise the insertion of at least one spacer between the first andsecond parts, and/or attaching a brace to the first and second arms ofthe hyoid bone support to expand the distance between the first arm andthe second arms. The changing the configuration step may be accomplishedeither before or after the attaching steps.

In one implementation of the invention, the attaching step comprisesattaching the first and second arms to the hyoid bone using screws.Alternatively, the attaching step may comprise using one or more boneclips, sutures, adhesives, or other attachment techniques known in theart.

The hyoid bone also comprises an arc length along the bone, between theends of the first and second greater horns. Any of the foregoing methodsmay additionally comprise the step of increasing the arc length of thehyoid bone, such as by separating the hyoid bone into two or morecomponent parts and providing a space between the adjacent parts. Thebone components may then be secured with respect to each other.

In accordance with a another embodiment of the present invention, thereis provided a method of treating a patient. The method comprisesidentifying the hyoid bone, having a first and second greater horns anda midpoint on the hyoid bone halfway between the ends of the first andsecond greater horns such that a first line extending from the midpointthrough an end of the first greater horn and a second line extendingfrom the midpoint through an end of the second greater horn define anangle. The angle is changed and the hyoid bone is secured to retain thechanged angle. Access to the hyoid bone may be accomplished in aminimally invasive procedure.

In accordance with another embodiment of the invention, there isprovided still another method for treating a patient. The methodcomprises the steps of providing a pharyngeal support, having a firstarm and a second arm which are transformable from a moveablerelationship with respect to each other to a fixed relationship withrespect to each other. The first arm is positioned with respect to afirst part of the pharynx and the second part is positioned with respectto another part of the pharynx. The configuration of the pharynx ischanged and the support is secured in the fixed relationship.

The positioning step may comprise forming an interference fit in afascial plane in proximity to a pharyngeal wall or between twopharyngeal muscles. The pharyngeal muscles may be a suprahyoid muscleand/or an infrahyoid muscle.

In one implementation of the invention, the method further comprisesattaching at least one arm of the pharyngeal support to a part of thepharynx. The attaching step may be performed using a tissue anchor,hook, suture, clip or adhesive. The attaching step may occur before orafter the changing the configuration step.

There is provided in accordance with another aspect of the presentinvention an implant for positioning in a pharyngeal structure,comprising an implant body; a first tissue contact zone configured forcontacting a first portion of a pharyngeal structure, a second tissuecontact zone configured for contacting a second portion of a pharyngealstructure, a connection between the first and second contact zones whichallows movement of the first and second contact zones with respect toeach other and a lock carried by the body for fixing the relationshipbetween the first and second contact zones. The portion of a pharyngealstructure may comprise a suprahyoid muscle, an infrahyoid muscle or ahyoid bone.

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the disclosure herein,when considered together with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The structure and method of using the invention will be betterunderstood with the following detailed description of embodiments of theinvention, along with the accompanying illustrations, in which:

FIG. 1 is a sagittal view of the pharynx.

FIGS. 2A and 2B depict the hyoid bone with respect to the thyroid andcricoid cartilage in a lateral and anterior view, respectively. FIG. 2Cis a superior view of the hyoid bone.

FIG. 3 illustrates the musculature attached to the hyoid bone in alateral view.

FIG. 4 shows an anterior view of the musculature attached to the hyoidbone. The right side depicts the superficial musculature and the leftside shows the deep musculature.

FIGS. 5A and 5B are superior and lateral views of one embodiment of theinvention, with the hyoid brace in a folded position. FIGS. 5C and 5Dshow the brace in an unfolded position.

FIGS. 6A through 6C represent at least one embodiment of the invention,utilizing a clevis pin pivot joint and a combination of bone screws andhooks to attach the hyoid brace to the hyoid bone.

FIGS. 7A through 7D represent at least one embodiment of the invention,using various pivot joints.

FIG. 8A depicts a system suitable for practicing at least one embodimentof the invention, comprising two brace arms and a bridge. FIG. 8B showsthe brace arms attached to a hyoid bone and FIG. 8C illustrates theattachment of the bridge.

FIG. 9 depicts another embodiment of the invention with two brace armsand an adjustable width bridge.

FIG. 10 illustrates another embodiment of the invention with selectablebridge sizes.

FIG. 11A represents another embodiment of the invention with four bracearms. FIG. 11B shows the attachment of the four brace arms to multiplehyoid bone segments and FIG. 11C shows the widening of the hyoid bonesegments.

FIGS. 12A through 12D represent various embodiments of attaching thehyoid brace to the hyoid bone.

FIGS. 13A and 13B are anterior and superior views of one embodiment ofthe configuration lock of the hyoid brace where the locking interface isembedded within the hyoid brace.

FIGS. 14A and 14B are anterior and superior views of another embodimentof the configuration lock of the hyoid brace where the configurationlocking interface protrudes from the hyoid brace.

FIGS. 15A and 15B are lateral and end views of one embodiment of theinvention with a locking member having a rotational interface. FIG. 15Cshows the tool that inserts into the rotational interface. FIGS. 15D and15E are anterior and superior views of one embodiment of the inventionutilizing the locking member with the rotational interface.

FIGS. 16A and 16B depict embodiments of the invention with a grippablesurface on the locking member.

FIGS. 17A and 17B represent embodiments of the invention shows therelative position of the pivot joint and the configuration lock.

FIGS. 18A and 18B illustrate other embodiments of the configuration lockusing semi-flexible locking members. FIG. 18C is a cross sectional viewof the locking interface for the locking member of FIG. 18B.

FIGS. 19A and 19B depict embodiments of the invention with tiltablelocking interfaces.

FIGS. 20A and 20B show embodiments of the invention with partiallyflexible brace arms and a wire-based configuration lock.

FIGS. 21A and 21B illustrate one embodiment of configuration lockutilizing suture knots.

FIGS. 22A and 22B represent one embodiment of invention using a tensionspring.

FIG. 23A shows the anatomical position of the hyoid bone relative to thethyroid cartilage and other landmarks of the head and neck. FIGS. 23Bthrough 23G represents at least one embodiment of the inventioncomprising an attachment of separate brace arms to the hyoid bone,joining the two brace arms and generally fixing their relative spatialposition with suture or surgical wire.

FIGS. 24A through 24C depict various embodiments of spacers that may beused with the invention. FIG. 24D is an oblique view of an adjustablespacer in FIG. 23C.

FIGS. 25A and 25B are some embodiments of a delivery tool capable ofminimally invasive insertion.

FIG. 26A depicts one embodiment of an outer sheath. FIG. 26B depicts oneembodiment of a distal end of a delivery tool capable of inserting abrace arm next to a hyoid bone in a minimally invasive procedure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A. Anatomy of the Pharynx

FIG. 1 is a sagittal view of the structures that comprise the pharyngealairway and may be involved in obstructive sleep apnea. The pharynx isdivided, from superior to inferior, into the nasopharynx 1, theoropharynx 2 and the hypopharynx 3. The nasopharynx 1 is less commonsource of obstruction in OSA. The nasopharynx is the portion of thepharynx above the soft palate 4. In the nasopharynx, a deviated nasalseptum 5 or enlarged nasal turbinates 6 may occasionally contribute toupper airway resistance or blockage. Only rarely, a nasal mass, such asa polyp, cyst or tumor may be a source of obstruction.

The oropharynx 2 comprises structures from the soft palate 4 to theupper border of the epiglottis 7 and includes the hard palate 8, tongue9, tonsils 10, palatoglossal arch 11, the posterior pharyngeal wall 12and the mandible 13. An obstruction in the oropharynx 2 may result whenthe tongue 9 is displaced posteriorly during sleep as a consequence ofreduced muscle activity during REM sleep. The displaced tongue 9 maypush the soft palate 4 posteriorly and may seal off the nasopharynx 1from the oropharynx 2. The tongue 9 may also contact the posteriorpharyngeal wall 12, which causes further airway obstruction.

The hypopharynx 3 comprises the region from the upper border of theepiglottis 7 to the inferior border of the cricoid cartilage 14. Thehypopharynx 3 further comprises the hyoid bone 15, a U-shaped, freefloating bone that does not articulate with any other bone. The hyoidbone 15 is attached to surrounding structures by various muscles andconnective tissues. The hyoid bone 15 lies inferior to the tongue 9 andsuperior to the thyroid cartilage 16. A thyrohyoid membrane 17 and athyrohyoid muscle 18 attaches to the inferior border of the hyoid 15 andthe superior border of the thyroid cartilage 16. The epiglottis 7 isinfero-posterior to the hyoid bone 15 and attaches to the hyoid bone bya median hyoepiglottic ligament 19. The hyoid bone attaches anteriorlyto the infero-posterior aspect of the mandible 13 by the geniohyoidmuscle 20.

The position of the hyoid bone relative to the thyroid and cricoidcartilage is shown in FIGS. 2A and 2B. The hyoid bone is a U-shaped bonecomprising a body 21, two lesser horns 22 and two greater horns 23, as ashown in a superior view in FIG. 2C. As shown in FIG. 3, at thepharyngeal level of the hyoid bone, the hyoid bone forms an anteriorportion of the pharynx while a pair of middle constrictor muscles 24form the remaining portions of the airway. The muscle fibers of themiddle constrictor muscles 24 originate from the greater 23 and lesserhorns 22 of the hyoid bone 15 and fan out posteriorly, inferiorly andsuperiorly to the posterior midline pharynx (not shown). A stylohyoidligament 25 attaches from the cranium to the hyoid bone. FIG. 4illustrates the attachments of the extrinsic muscles of the larynx. Theleft side of the illustration in FIG. 4 depicts the anatomy of thesuperficial musculature and the right side depicts the deepermusculature. The posterior belly 26 of the digastric muscle originatesfrom the mastoid process 27 and attaches to the lesser horn 22 of thehyoid bone 15 as a tendon and then attaches as an anterior belly 28 tothe mandible 13. The stylohyoid muscle 29 originates from the styloidprocess (not shown) of the cranium and then splits into two portionsupon inserting adjacent to the lesser horn of the hyoid bone 15 to allowthe digastric muscle to pass anteriorly. Deep to the digastric 26, 28and stylohyoid 29 muscles are the hyoglossus muscles 30, attaching tothe superior surfaces of the greater horns 23 of the hyoid bone 15 andinserting into the lateral areas of the tongue 9. Further deep is themylohyoid muscle 31, a sheet of muscle that courses between the hyoidbone 15 and the lateral interior sides of the mandible 13, forming aportion of the musculature of the floor of the mouth along with thegeniohyoid muscle 20. These muscles move the hyoid bone 15 and tongue 9superiorly and anteriorly, and are involved in the act of swallowing.Overlying most of the antero-lateral neck is the platysma muscle (notshown) that originates over the upper anterior chest and inserts overthe anterior surfaces of the mandible 13.

The omohyoid muscles 32 are the most lateral of the muscles that attachto the inferior surface of the hyoid bone 15. The omohyoid muscles 32also has two bellies. The inferior belly 33 attaches to the scapula andthe superior belly 34 attaches to the inferior body of the hyoid bone.The two bellies 33, 34 are joined by a tendon 32 that is continuous withfascia along the medial ends of the clavicles 46. Also attached to theinferior surfaces of the hyoid bone are the sternohyoid muscles 35 thatoriginate at the manubrium 36 of the sternum and the thyrohyoid 18muscles that originate along antero-inferior border of the thyroidcartilage 16. The inferior muscles of the hyoid bone act to increase theluminal opening of the pharynx at the level of the hyoid.

B. Hyoid Brace

In one embodiment shown in FIGS. 5A and 5B, the hyoid brace orhyoidplasty implant comprises at least two brace arms 39, each with alateral end 40, a medial end 41, an inner surface 42 capable of facingthe hyoid bone or portion thereof, an outer surface 43, a superiorsurface 44 and an inferior surface 45. Hyoidplasty, as used herein,shall be given its ordinary meaning, and shall also include anyalteration in the configuration or location of the hyoid bone or bonesegments, including changes in angulation, anterior-posteriordimensions, lateral wall dimensions and/or removal of at least a portionof the hyoid bone. In one embodiment, the hyoid brace also has a flexpoint such as a pivot joint that joins the two brace arms 39. The pivotjoint provides the hyoid brace with a folded position and a unfoldedposition. In the folded position, shown in FIG. 5B, the two lateral ends40 of the hyoid brace are in closer proximity with one another. In theunfolded position, shown in FIG. 5C, the two lateral ends 40 are fartherapart. FIG. 5D depicts the hyoid brace in proximity to the hyoid bone.

In one embodiment shown by FIG. 6A, the flex point comprises a clevispin 51. In another embodiment, the flex point comprises a hinge joint47, as in FIG. 7A. In a further embodiment, the hinge joint is limitedto a particular range of movement. In one embodiment, shown in FIG. 7B,the pivot joint comprises a ball and socket joint 48. In anotherembodiment depicted in FIG. 7C, the pivot joint comprises one or morewires 49. In another embodiment, the wires resist axial loading. Inanother embodiment, the wires resist axial loading but are capable oflimited flexion. In another embodiment, the pivot joint comprises one ormore ribbons 50, as illustrated in FIG. 7D.

In another embodiment depicted in FIG. 8A, the hyoid brace comprises twobrace arms 52 and a bridge 53 that is fastenable to the two brace arms50. The brace arms 52 are attachable to the hyoid bone 15, as shown inFIG. 8B. When fastened to the brace arms 52, the bridge 53 is capable ofaltering the relative spatial orientation of the brace arms 52. In oneembodiment, push members 54 protrude from the inner surface 55 of thebridge 53 to apply force to the medial ends 41 of the brace arms 52. Inone embodiment, the bridge 53 has a wider shape than the curvature ofthe hyoid bone 15 and may spread apart the greater horns 23 of the hyoidbone upon attachment to the brace arms 52. In one embodiment in FIG. 8C,the bridge 53 has both push members 54 and a wider shape. The bridge 53optionally allows lateral displacement of the hyoid bone in addition towidening of the angle. In still another embodiment, the hyoid bonesegments are laterally displaced but the relative angle of the twopieces is generally unchanged. In one embodiment, shown in FIG. 9,lateral displacement is provided by a slotted tongue 54 inserted into ascrew mechanism 55. Similarly, anterior-posterior displacement may occurif the tongue 54 and screw mechanism 55 were positioned more laterallyalong the hyoid bone 15. The bridge 53 attaches to the brace arms 39 byclips 56. In another embodiment in FIG. 10, the operator will select abridge 53 from a variety of sizes to fasten to the brace arms 52 andalter the separation of the brace arms 52 and the attached hyoid bone.The bridge may attach to the brace arms through eyelets 57 or slots onthe outer surface 43 of the brace arms 52. In still another embodiment,the bridge 53 and the brace arms 52 have connectors (not shown) to allowsuturing of the hyoid brace to surrounding structures and to furthermodify the hyoid bone position.

In one embodiment, the hyoid brace may have more than two segments 58which are attached by two or more pivot joints or bridges, as in FIG.11.

1. Attachment of the Hyoid Brace to the Hvoid Bone or Bone Segments

In one embodiment, the hyoid brace is attached to the hyoid bone 15 orhyoid bone segments. In one embodiment illustrated in FIG. 12A, bonescrews 59 are used to attach the hyoid brace. In another embodiment inFIG. 12B, the attachment occurs with clips 60 on the brace. In anotherembodiment in FIG. 12D, the brace is attached using sutures or surgicalwire 61. In one embodiment in FIGS. 6A and 6B, hooks 62 are used toattach the hyoid brace to the hyoid bone 15. In another embodiment,adhesives are used to attach the hyoid brace. In another embodiment,illustrated in FIG. 6A, a combination of attachments are used.

In one embodiment shown in FIG. 12A, the hyoid brace is attachable tothe hyoid bone 15 or bone segments by bone screws 59. The hyoid bracemay have one or more screw holes 63 that run from the outer surface tothe inner surface 42 of the brace arm 39. In one embodiment, the screwholes 63 or other landmarks on the hyoid brace allow the operator toidentify the location of the holes 63 by palpation or by radiographicmethods. With the identification of the location of the screw holes, anoperator may create additional access for drilling into the hyoid bone15 or bone segments and for securing the hyoid brace to the hyoid bone15 or bone segment by inserting a bone screw 59 through the hyoid braceand screw hole 63.

In one embodiment shown in FIGS. 12B and 12C, the hyoid brace comprisesclips 60, the clips 60 having a plurality of partially flexible members64 extending from superior 44 and/or inferior 45 surfaces of the bracearms 39. The partially flexible members 64 have a distal end 65 and aconfiguration with an inner surface 66 facing the hyoid bone. Theconfiguration may be any path capable of transiting from one point on orabout the hyoid bone 15 to another point on or about the hyoid bone thatis sufficient to resist displacement of the hyoid brace arms 39 from thehyoid bone 15. The configuration may be a square bracket or a curvedclip. The members 64 are sufficiently flexible such that with anapplication of force against the member 64, the distal ends 65 of themembers will flex apart from each other. In one embodiment, where theforce results from pressing the brace arm 39 against the hyoid bone 15,the flexion allows the hyoid bone 15 or bone segment to come inproximity of the inner surface of the hyoid brace arm 39. After contact,the flexible members 64 reverts back to their previous configuration andsecures the brace arms 39 to the hyoid bone 15 or bone segments.

In one embodiment, sutures 61 are removably attached to the hyoid brace.In one embodiment, depicted in FIG. 12D, the sutures 61 are used toattach the hyoid brace to the hyoid bone 15 or hyoid bone segments. Thesuture 61 may be cut after the brace arms are attached. Optionally,these sutures 61 may be attached to surrounding structures in the neckor mandible to provide additional support or anchoring of the hyoidbrace and hyoid bone. In another embodiment, the sutures may be broughtout through the skin to provide additional control of the lateral ends40 of the brace during the attachment procedure. In one embodiment, thesutures 61 are attached to the lateral ends 40 of the brace arms 39. Inanother embodiment, sutures 61 are attached to the lateral 40 and medialends 41 of the brace arms 39.

In another embodiment shown in FIGS. 6A and 6B, the hyoid bracecomprises at least one hook 62 extending from at least one arm of thehyoid brace. The hook may pierce a portion of the surroundingmusculature or connective tissue to engage the hyoid brace with thehyoid bone 15 to at least partially hold the hyoid brace next to thehyoid bone 15. In one embodiment, the hyoid brace is positioned adjacentto the hyoid bone 15 and then rotated about its longitudinal accessuntil the hooks engage around the hyoid bone. A portion or all of thebrace arm 52 may comprise a helical configuration, so that it may bedistally advanced with rotation to encircle the corresponding greaterhorn 23 of the hyoid bone 15.

In another embodiment, an interference fit is provided between the hyoidbrace and hyoid bone by creating a passage through at least a portion ofthe hyoid bone and inserting the brace arm or extension therefrom intothe passage. In one embodiment, the passage is created through an innercore of the hyoid bone. In another embodiment, the passage extendsbetween an outer anterior or lateral surface of the hyoid bone and aninner surface of the hyoid bone. A hyoid brace inserted into the passagefrom the outer to inner surface of the hyoid bone allows manipulation ofthe hyoid brace to apply a, outward force to the inner surface of thehyoid bone. Alternatively, the hyoid brace may originate from about theouter anterior surface of the hyoid bone, extend bilaterally over thesuperior or inferior surfaces to contact the inner surfaces of the hyoidbone and apply a radially outward force.

In another embodiment of the present invention, the hyoid brace isadapted for implantation in the tissue adjacent to the hyoid bone orother tissue comprising the pharynx. The pharynx, as used herein, isgiven its ordinary meaning and also includes the pharyngeal mucosa,pharyngeal submucosa, pharyngeal musculature, hyoid bone, infrahyoidmuscles, suprahyoid muscles and any connective tissue between. The braceis inserted into the soft tissue adjacent to the hyoid bone orpharyngeal wall and manipulated to exert sufficient force to dilateportions of the pharyngeal wall or support the pharyngeal walls fromcollapse. The screws, clips, hooks or sutures of the previousembodiments of the invention or other soft tissue anchors may be adaptedto secure the brace to the soft tissue of the pharyngeal wall. Inanother embodiment, the implant resides within and relies on the naturalfascial planes of the neck musculature to affix its position and doesnot require any additional attachment to muscle. In one embodiment, thebrace arms are inserted into fascial planes between the stylohyoid andhyoglossus muscles. In another embodiment, the brace arms are insertedinto the fascial planes between the hyoglossus and mylohyoid muscles. Inanother embodiment, the brace arms are inserted posterior to theposterior belly of the digastric muscle and anterior to the stylohyoidmuscle. In still another embodiment, the brace arms are placed betweenthe superior belly of the omohyoid and thyrohyoid muscles. The bracearms are then manipulated to achieve a lateral separation and thenlocked or caused by internal bias to retain their relative positions.

2. Configuration Lock of the Hvoid Brace

In one embodiment, shown in FIGS. 13A and 13B, a configuration lock 67is located between the two brace arms 39 and is attachable to both bracearms 39. The configuration lock 67 comprises a locking member 68 with atleast one interfaceable end 69 and at least one locking interface 70located on a brace arm 39. When the interfaceable end 67 of the lockingmember 68 is in contact with the locking interface 70 of the brace arms39, the locking member 68 limits the movement, if any, of a brace arm 39relative to the other brace arm 39 or brace arms 39.

In one embodiment, the locking member 68 comprises an elongated member71 with two interfaceable ends 67 at least one of which comprises athreaded end 72. Each brace arm 39 has an interface for receiving themember 71, at least one of which has a locking interface 70 comprising athreaded hole 73. The threaded hole 73 is matched to the threaded ends72 of the elongated member 71 such that the elongated member 71 may passaxially through the threaded hole 73 by applying a rotation force to theelongated member 71. In one embodiment, the locking interface 70comprises a threaded hole 73 within a cavity 74 of the brace arm 39. Thecavity 74 may have one or more openings 75. When the threaded ends 72 ofthe elongated member 71 are screwed into the threaded locking interfaces70, the relative position and angle formed by the brace arms 39 may befixed. In one embodiment, the position and angle may be reversiblyadjusted by rotating the elongated member 71. In one embodiment, thelocking interface 70 comprises a threaded hole 73 in a protrusion 76from the brace arm 39, shown in FIGS. 14A and 14B.

As is illustrated herein, a variety of different configurations of theimplant may be devised in which a rotatable threaded shaft 71, depictedin FIG. 15A, is utilized both to adjust the angular orientation of theimplant, as well as retain the implant in a predetermined orientation.This allows the clinician to rotate a driver tool 78, represented inFIG. 15C, coupled to the rotatable shaft 71 thereby adjusting theangular orientation of the implant throughout a continuous range. Oncethe desired manipulation of the hyoid bone 15 has been accomplished, thedeployment tool 78 may be decoupled from the rotatable shaft 71, and theimplant will retain its predetermined configuration.

The adjustment tool 78 (e.g., an elongate rotatable shaft having ananti-rotation coupling thereon for interlocking with a correspondingcomplementary interlocking surface on the rotatable shaft 71) may beoriented coaxially with the rotatable shaft 71. In this configuration, alinear coaxial access lumen is preferably provided such as bylengthening the lumen or threaded hole 73 along its longitudinal axisthrough the implant until it exits the implant, thereby enabling directaxial connection of the adjustment tool. This lateral approach isillustrated, for example, in FIG. 15E, however may be applied to any ofthe rotational embodiments herein.

Alternatively, it may be desirable to adjust the implant from ananterior approach. In this configuration, a 90° or other bend in theaxis of rotation may be provided, utilizing gear mechanisms wellunderstood in the art, allowing the rotation of an adjustment tool whichlies along an anterior-posterior axis to translate rotation into theelongated member 71, which lies in a lateral axis perpendicular or at anon normal angle to the anterior-posterior axis.

In one embodiment, represented in FIG. 15A, one or both of the threadedends 72 may optionally have a rotation interface 77, as in FIG. 15B, sothat the tool 78, seen in FIG. 15C with a complementary interface 79 canbe applied to the threaded end 72 to facilitate rotation of theelongated member 71. The rotation interface 77 may comprise a slot inthe end of the elongated member 71 and the tool 78 comprises ascrewdriver with a complementary interface 79 comprising a flat endfittable to the slot. In another embodiment, the rotation interface 77is a hex or other noncircular configuration recess or projection headand the tool 78 is a hex screwdriver or other complementary surfacestructure. In one embodiment, depicted in FIGS. 15D and 15E, the cavity74 containing the locking interface 70 has at least two openings 75. Oneopening 75 accepts the threaded end 72 of the elongated member 71.Another opening 75 provides access to the rotation interface 77 of theelongated member 71.

As will be appreciated in view of the disclosure herein, rotation of theelongated member 71 in a first rotational direction will advance theelongated member 71 distally along its longitudinal axis, therebyclosing the angle between the first and second arms of the implant.Rotation of the elongated member 71 in an opposite direction will enableopening of the angle between the first and second arms of the implant.In this manner, the angular orientation of the arms of the implant maybe adjusted throughout an angular range.

In another embodiment, the elongated member 71 further comprises agrippable surface between the two threaded ends 72. In one embodiment,illustrated in FIG. 16A, the grippable surface comprises a dial 81. Inone embodiment, shown in FIG. 16B, the grippable surface comprises twoor more flat surfaces 82 along the elongated member 71.

In one embodiment, depicted in FIG. 17A, the pivot joint of the hyoidbrace is located closer to the inner (posterior) surface 42 of the hyoidbrace relative to a configuration lock 67. In another embodiment,represented in FIG. 17B, the pivot joint is located closer to the outer(anterior) surface 43 of the hyoid brace relative to the configurationlock 67. Thus, the threaded shaft 67 may be located such that it iseither under tension or under compression while restraining the hyoidbone in its modified orientation.

In another embodiment, shown in FIG. 18A, the locking member 68comprises an elongated member 71 that is semi-flexible and has a rampedsurface 83 that allows insertion through a locking interface 70 in onedirection but acts as a ratchet to resist movement in the oppositedirection. In another embodiment, illustrated in FIG. 18B, the lockingmember 68 comprises a beaded wire 84 with a locking interfaces 70 thatallows passage of wire 85 but not beads 86, as seen in FIG. 18C.

In one embodiment, one or more locking interfaces 68 may provide somerelative movement between itself and the brace arm 39 to which it isattached. This relative movement may be desirable to accommodate angularchanges in the position between the locking member 68 with the brace arm39 as the configuration lock 67 is adjusted to the desired position. Inone embodiment, illustrated in FIG. 19A, the locking interface 70provides some relative movement through limited flexibility of aprotrusion 76 of the brace arm 39. In another embodiment, relativemovement is provided by hinge joints (not shown) attaching the lockinginterfaces to the brace arms. In another embodiment, depicted in FIG.19B, some relative movement is provided by a threaded nut 87 in a cavity74 of the brace arm 39 that is slightly loose in the cavity 74 to allowsome tilting of the threaded nut 87, but is not enough to allow rotationor longitudinal displacement of the nut 87 within the cavity 74. Thecavity 74 may provide entry of the locking member 68 at a range ofangles.

In another embodiment, depicted in FIG. 20A, the brace arms 39 of thehyoid brace are pivotable and/or semi-flexible and the locking member 68comprises wires 90 with proximal 91 and distal ends 92 that areslideable along conduits 93 located in the brace arms 39 closer to theouter surface 43, and a cinching member 94 that controls the sliding ofwires 90. The locking interfaces 68 of the brace arms 39 comprise anattachment of the distal ends 92 of the wires 90 to the lateral ends 40of the brace arms 39. As the wires 90 are pulled from a lateral tomedial direction, the inner 42 and outer surfaces 43 of the brace arms39 will shift at different rates and cause the brace arms 39 to flexoutward and widen the angle formed by the attached hyoid bone 15 orhyoid bone segments. In another embodiment, shown in FIG. 20B, theconduits 93 comprise a plurality of eyelets 95 protruding from the outersurface 43 of the brace arms 39. In another embodiment shown in FIGS.11A to 11C, more than two brace arms 39 are used with the wire-basedconfiguration lock. In one embodiment, the cinching member 94 mayreversibly control the sliding of the wires 90 through reversiblefriction. In another embodiment, the cinching member 94 reduces slidingof the wires 90 through heating bonding to the wires 90.

In another embodiment, represented in FIGS. 21A and 21B, the lockinginterface comprises a plurality of holes 96 on the brace arms 39 withthe configuration lock comprising at least one suture 97 threadedbetween holes 96 on two different brace arms 39.

In one embodiment, as shown in FIG. 22A, a torsion spring 98 is locatedabout a hinge joint 47. The torsion spring 98 has two ends 99, depictedin isolation in FIG. 22B, that extend distally to apply force to thebrace arms 39 to widen the angle formed by the brace arms to the maximumallowed by the hinge joint. The ends 99 of the torsion spring 98 may beembedded within the brace arms 39 or the ends 99 may found external tothe brace arms 39 against the inner surface 42 of the brace arms. Thespring tension may be selected to allow at least narrowing of the angleformed by the brace arms during swallowing or speaking.

3. Materials for Construction of the Hyoid Brace

For the embodiments discussed herein, the hyoid brace, together with theconfiguration lock and other components of the present invention can bemanufactured in accordance with any of a variety of techniques which arewell known in the art, using any of a variety of medical-gradeconstruction materials. For example, the hyoid brace and othercomponents of the present invention can be injection-molded from avariety of medical-grade polymers including high or other densitypolyethylene, nylon and polypropylene. Portions of the configurationlock can be separately formed from the brace arms and secured thereto ina post-molding operation, using any of a variety of securing techniquessuch as solvent bonding, thermal bonding, adhesives, interference fits,pivotable pin and aperture relationships, and others known in the art.Preferably, however, the configuration lock is integrally molded withthe brace arms, if the desired material has appropriate physicalproperties.

A variety of polymers which may be useful for the hyoid brace componentsof the present invention are identified below. Many of these polymershave been reported to be biodegradable into water-soluble, non-toxicmaterials which can be eliminated by the body:

Polycaprolactone

Poly (L-lactide)

Poly (DL-lactide)

Polyglycolide

Poly (L-Lactide-co-D, L-Lactide)

70:30 Poly (L-Lactide-co-D, L-Lactide)

95:5 Poly (DL-lactide-co-glycolide)

90:10 Poly (DL-lactide-co-glycolide)

85:15 Poly (DL-lactide-co-glycolide)

75:25 Poly (DL-lactide-co-glycolide)

50:50 Poly (DL-lactide-co-glycolide)

90:10 Poly (DL-lactide-co-caprolactone)

75:25 Poly (DL-lactide-co-caprolactone)

50:50 Poly (DL-lactide-co-caprolactone)

Polydioxanone

Polyesteramides

Copolyoxalates

Polycarbonates

Poly (glutamic-co-leucine)

The desirability of any one or a blend of these or other polymers can bedetermined through routine experimentation by one of skill in the art,taking into account the mechanical requirements, preferred manufacturingtechniques, and desired reabsorption time. Optimization can beaccomplished through routine experimentation in view of the disclosureherein.

Alternatively, the hyoid brace components can be molded, formed ormachined from biocompatible metals such as Nitinol, stainless steel,titanium, and others known in the art. In one embodiment, the componentsof the hyoid brace are injection-molded from a bioabsorbable material,to eliminate the need for a later removal step or to promote fibrosisand fixation of adjacent structures. One suitable bioabsorbable materialwhich appears to exhibit sufficient structural integrity for the purposeof the present invention is poly-p-dioxanone, such as that availablefrom the Ethicon Division of Johnson & Johnson. Poly (L-lactide, orco-DL-lactide) or blends of the two may alternatively be used. As usedherein, terms such as bioabsorbable, bioresorbable and biodegradableinterchangeably refer to materials which will dissipate in situ,following a sufficient post-operative period of time, leaving acceptablebyproducts. Bodily reaction to the bioabsorbable materials or byproductsmay furnish at least a portion of the support provided by the device ortreatment method. All or portions of any of the devices herein, as maybe appropriate for the particular design, may be made from allograftmaterial, or synthetic bone material.

The bioabsorbable implants of this invention can be manufactured inaccordance with any of a variety of techniques known in the art,depending upon the particular polymers used, as well as acceptablemanufacturing cost and dimensional tolerances as will be appreciated bythose of skill in the art in view of the disclosure herein. For example,any of a variety of bioabsorbable polymers, copolymers or polymermixtures can be molded in a single compression molding cycle, or thesurface structures can be machined on the surface of the hyoid braceafter the molding cycle. It is also possible to use the techniques ofU.S. Pat. No. 4,743,257, the entire disclosure of which is incorporatedherein by reference, to mold absorbable fibers and binding polymerstogether.

An oriented or self-reinforced hyoid brace can also be created duringextrusion or injection molding of absorbable polymeric melts through asuitable die or into a suitable mold at high speed and pressure. Whencooling occurs, the flow orientation of the melt remains in the solidmaterial as an oriented or self-reinforcing structure. The mold can havethe form of the finished brace component, but it is also possible tomanufacture the brace components of the invention by machininginjection-molded or extruded semifinished products. It may beadvantageous to make the hyoid brace from melt-molded, solid state drawnor compressed, bioabsorbable polymeric materials, which are described,e.g., in U.S. Pat. Nos. 4,968,317 and 4,898,186, the entire disclosuresof which are incorporated herein by way of this reference.

Reinforcing fibers suitable for use in the components of the presentinvention include ceramic fibers, like bioabsorbable hydroxyapatite orbioactive glass fibers. Such bioabsorbable, ceramic fiber reinforcedmaterials are described, e.g., in published European Patent ApplicationNo. 0146398 and in WO/96/21628, the entire disclosures of which areincorporated herein by way of this reference.

As a general feature of the orientation, fiber-reinforcement orself-reinforcement of the brace components, many of the reinforcingelements are oriented in such a way that they can carry effectively thedifferent external loads (such as tensile, bending and shear loads) thatare directed to the hyoid brace as used.

The oriented and/or reinforced hyoid brace materials for manyapplications have tensile strengths in the range of about 100-2000 MPa,bending strengths in the range of about 100-600 MPa and shear strengthsin the range of about 80-400 MPa, optimized for any particular designand application. Additionally, they are relatively stiff and tough.These mechanical properties may be superior to those of non-reinforcedor non-oriented absorbable polymers, which often show strengths betweenabout 40 and 100 MPa and are additionally may be flexible or brittle.See, e.g., S. Vainionpaa, P. Rokkanen and P. Tormnld, “SurgicalApplications of Biodegradable Polymers in Human Tissues”, Progr. Polym.Sci., Vol. 14, (1989) at 679-716, the full disclosure of which isincorporated herein by way of this reference. In other embodiments ofthe present invention, a semi-flexible material is desired to provide aresilience so that normal swallowing and speaking are not impaired.

The brace components of the invention (or a bioabsorbable polymericcoating layer on part or all of the brace surface), may contain one ormore bioactive substances, such as antibiotics, chemotherapeuticsubstances, angiogenic growth factors, substances for accelerating thehealing of the wound, growth hormones, antithrombogenic agents, bonegrowth accelerators or agents, and the like. Such bioactive implants maybe desirable because they contribute to the healing of the injury inaddition to providing mechanical support.

C. Placement of a Hyoid Brace

1. Surgical Approach

In one embodiment as depicted in FIG. 23A, the head of the patient isplaced in an extended position to facilitate access to the upper neck.The skin of the neck is sterilized and draped using procedures wellknown to those with skill in the art. Applying sterile technique andusing the thyroid cartilage 16 as a landmark, the hyoid bone 15 ispalpated, if possible, and an incision site is identified about themidline of the hyoid bone. In one embodiment, the skin is injected withanesthetic containing epinephrine until anesthesia is achieved. About a2 to about a 5 cm incision is made in the skin generally overlying themidportion of the hyoid bone 15. In one embodiment, the incision is avertical incision, shown in FIG. 23B. In another embodiment, theincision is a horizontal incision. The subcutaneous tissue is dissecteduntil the platysma muscle is reached. Skin retractors are used tomaximize and maintain the visibility of the exposed incision site. Atleast a 1 cm vertical midline incision is made in the platysma muscle toexpose at least a portion of the hyoid bone. Blunt dissection is thenperformed along the hyoid bone 15 to each lateral side of the incisionsite to create a dissected space and to facilitate insertion of a hyoidbrace along the anterior surface of the hyoid bone 15. Muscles attachedto the hyoid bone may be transected to facilitate visibility of thesurgical site, attachment of the hyoid brace, expansion of thepharyngeal airway, or to alter the movement of the hyoid bone, but isnot limited to any these particular purposes. The hyoid brace is thenattached to the hyoid bone as previously described and illustrated inFIGS. 23C through 23G. In one embodiment, additional access sites arecreated to the dissected space. Additional access sites may be createdby passing an instrument from the dissected space out through the skinof the neck. In another embodiment, access sites are created bypuncturing the skin of the neck and inserting an instrument to thedissected space. Other variant approaches will be apparent to thoseskilled in the art, such as otolaryngologists, including endopharyngealapproaches. In another embodiment, a midline incision is made in theskin about 2 to about 4 cm above the hyoid bone and the subcutaneoustissue is dissected until the suprahyoid muscles are reached. The braceis attached to the suprahyoid musculature or inserted into fascialplanes between the suprahyoid muscles. The suprahyoid muscles may bedissected further to implant the brace closer to the inner wall of thepharynx. In another embodiment, the midline incision is made about 1 toabout 4 cm below the hyoid bone and the brace is inserted into orattached to the infrahyoid musculature.

In one embodiment, the hyoid bone 15 is not cut but is bent to a widerangle. In another embodiment, the hyoid bone 15 is cut prior to theinsertion of the hyoid brace. In another embodiment the hyoid bone 15 iscut after the insertion of the hyoid brace into the dissection space butprior to the attachment of the hyoid brace to the hyoid bone 15. Instill another embodiment, the hyoid bone 15 is cut after the brace isattached to the hyoid bone 15. In another embodiment, the brace isadjustable after attachment to the hyoid bone 15 such that position andangle of the hyoid bone segments may be reversible changed at any time.In one embodiment, the segments of the hyoid bone 15 may immediatelyassume the desired position and angle after cutting from of the forcesapplied to the hyoid bone segments by the attached brace. In oneembodiment the hyoid bone 15 is cut at about the midline. In anotherembodiment the hyoid bone is cut anywhere between the lesser horns. Inanother embodiment the hyoid bone is cut anywhere between the greaterhorns. In another embodiment, the hyoid bone is cut into multiplesegments. In another embodiment the hyoid bone is cut twice, with eachcut made just at or about medial to each lesser horn. In one embodiment,illustrated in FIGS. 24A and 24B, a spacer 120 is inserted between orabout the hyoid bone segments. In one embodiment, represented in FIGS.24C and D, the spacers 121 are adjustable in size after insertion. Inanother embodiment, graft materials (not shown) are inserted between orabout the hyoid bone segments. The graft material may be an autograft,allograft, xenograft or synthetic. Synthetic graft material beceramic-based, silicon-based or calcium-based. The graft material mayalso include osteoinductive factors to promote bone ingrowth. In anotherembodiment, spacers and synthetic graft material are inserted between orabout the hyoid bone segments. One skilled in the art will appreciatethat there are many varieties of synthetic graft materials andconstituents that may be used to between or about the hyoid bonesegments.

In one embodiment, the brace is adjustable after attachment to the hyoidbone 15 such that position and angle of the hyoid bone segments may bereversibly changed at any time. In one embodiment, after the hyoid braceis attached to the hyoid bone 15 or bone segments, the attachment of thebrace is checked and adjusted if necessary and the incision and puncturesites are closed as known by those skilled in the art. In one embodimentthe incision sites are closed by sutures. In another embodiment theincision sites are closed by adhesives. In another embodiment, the woundis covered with dressings. In one embodiment, airway patency is assessedduring the procedure and for a period of time after the procedure toensure stability of the brace and hyoid bone. In one embodiment, suturesare optionally used to permanently or temporarily stabilize the hyoidbone or bone segments for attachment of the hyoid brace. The sutures areplaced around the hyoid bone so that the free ends of the sutures extendoutside the body and the operator may apply a pulling force to thesutures to resist any inward force applied to the hyoid bone or bonesegment during the attachment process. Alternatively, the sutures may beattached to other structures of the body.

In one embodiment, the apparatus and method for hyoidplasty is adaptedto repair a fractured hyoid bone resulting from neck trauma.

2. Minimally Invasive Approach

a. Delivery Member for the Hyoid Brace

One embodiment of the invention, shown in FIG. 25A, comprises a deliverymember 100 having a core 101 with a proximal end 102 and a distal end103, an outer sheath 104 with a proximal end 105 and a distal end 106and a fastener with a proximal end 108 and distal end 109. In oneembodiment, the delivery member 100 is a flexible catheter. In anotherembodiment, the delivery member is a rigid instrument. In oneembodiment, the delivery member 100 further comprises a handle 110 atthe proximal end 102 of the core 101. The delivery member 100 hassufficient rigidity to direct the placement of the hyoid brace or bracecomponents through various thicknesses of subcutaneous tissue. The hyoidbrace or brace components are attachable to the distal end 103 of thecore 101 by a fastener 107. In one embodiment, the fastener 107comprises a clamp 111 or forceps attached to the distal end 103 of thecore 101 that may be optionally controlled by the proximal end 108 ofthe fastener 107 located at the proximal end 102 of the core 101 througha push button 112 or a squeeze lever that releases the clamp 111 orforceps, as is known to those skilled in the art. In another embodiment,depicted in FIG. 25B, the fastener 107 is a wire 113 or suture thatextends through the core 101 from proximal to distal, loops around thehyoid brace near the medial ends of the hyoid brace and extends backthrough the core 101 from distal to proximal. Both ends of the wire 113or suture are located at the proximal end 102 of the core 101 and areattached to a proximal anchor 115. In one embodiment, the wire 113 orsuture is sufficiently taut to hold a portion of the hyoid brace againstthe distal end 103 of the core 101. A outer sheath 104 is positionedaround the distal end of the core, having an extended position and aretracted position. In the extended position, the outer sheath 104generally overlies the hyoid brace. In one embodiment, the outer sheath104 in the extended position prevents the hyoid brace from changing froman unfolded position to a folded position. In the retracted position,the hyoid brace is generally exposed and the outer sheath 104 does notprevent the hyoid brace from unfolding. In one embodiment, an outerprojection 116 on the core 101 and an inner projection 117 on the outersheath 104 block the outer sheath 104 from extending past an extendedposition. The hyoid brace is releasable from the distal end 103 of thecore 101 by freeing one end of the wire 113 or suture and pulling thewire 113 proximally to remove the loop of wire or suture about themedial ends 41 of the hyoid brace.

In another embodiment, illustrated in FIGS. 26A and 26B, the deliverymember comprises a catheter or insertion tool having a core 101 with aproximal end (not shown) and distal end 103, and an outer sheath 104.The distal end 103 of the core 101 has a surface 118 configured foraffixing brace arms 52 to the core 101. The outer sheath 104 isslideable along the length of the core 101 and is capable ofencompassing both the core 101 and the brace arms 52. The deliverymember is inserted into the dissected area and positioned to release thebrace arm 52 at a desired position. The outer sheath 104 is withdrawn toexpose the core and release the hyoid brace arm. The core surface 118 isconfigured to prevent mobility of the brace or parts thereof as theouter sheath is withdrawn, but is configured to allow withdrawal of thecore 101 while leaving the brace arm at the dissected site. In oneembodiment, the core 101 and outer sheath 104 allow attachment of thebrace arms 52 to the hyoid bone or bone segments prior to release of thebrace arm 52 in the dissected space. The outer sheath 104 has at leastone linear opening 119 along the distal end 106 of the outer sheath 104to allow sliding of the sheath 104 after the brace arm 52 has been atleast partially attached to the hyoid bone 15 or bone segments. In oneembodiment, at least one of the linear openings 119 has a shapeconformable to a hyoid bone 15 to facilitate alignment of the brace arm52 with the hyoid bone 15 or bone segments. In one embodiment, the outersheath 104 is capable of rotation around the core 101. In oneembodiment, rotation of the outer sheath 104 exposes the hooks 62 orclips 60 of the brace arm 52. In one embodiment, placing the outersheath 104 in a retracted position exposes the hooks 62 or clips 60.

In one embodiment, the delivery member 100 has a diameter ranging fromabout 16 French to about 22 French. In another embodiment, the diameterranges from about 10 French to about 22 French. In another embodiment,the diameter ranges from about 4 French to about 24 French. In oneembodiment, the delivery member has a length of about 6 cm to about 10cm. In another embodiment, the length is about 6 cm to about 20 cm.

In one embodiment, the outer sheath 104 has palpable markings (notshown) on the core 101 or outer sheath 104 for an clinician to determinethe location of the delivery member 100 by tactile sensing. In oneembodiment the palpable markings are used by the operator for theplacement of puncture access sites lateral to the midline incision site.In one embodiment the delivery member 100 has radiographically visibleembedded markers that are visible under fluoroscopy or plain filmx-rays. In one embodiment, the outer sheath 104 has a groove (not shown)to facilitate alignment of the delivery member 100 to the hyoid bone 15or bone segments.

In another embodiment, the delivery member 100 comprises one or moresutures brought through the initial incision site and extending throughthe dissected area along the hyoid bone 15 and exiting the body througha puncture site lateral to the initial incision site. The sutures may beused to guide the brace components to the intended attachment site andalso to attach the brace components to the hyoid bone.

In one embodiment, the delivery member further comprises one or moreguidewires inserted into the initial incision site. In one embodiment,the guidewire extends through the dissected area along the hyoid boneand exits the body through a puncture site lateral to the initialincision site. In one embodiment, the core 101 further comprises aguidewire lumen (not shown) running generally from the proximal end tothe distal end 103 of the core 101.

In one embodiment, the delivery member 100 has a blunt tip and may alsoserve as a blunt dissection instrument. Blunt dissection with thedelivery member 100 may be performed prior to attachment of the hyoidbrace or brace components to the delivery device 100, or concurrently asthe brace arm 52 is attached to the hyoid bone.

In one embodiment the manufacturer provides a hyoid brace that ispreattached to the delivery device 100. In another embodiment theoperator attach the hyoid brace to the delivery device 100 prior to use.In another embodiment the operator selects from a variety of braces withdifferent curvatures and configuration angles and attaches the brace tothe delivery device 100.

b. Procedure for Minimally Invasive Insertion

The head of the patient is placed in an extended position to facilitateaccess to the upper neck, as depicted in FIG. 23A. The skin of the upperneck is sterilized and draped using procedures well known to those withskill in the art. Applying sterile technique and using the thyroidcartilage as a landmark, the hyoid bone is palpated, if possible, and anincision site is identified about the midline of the hyoid bone. In oneembodiment, the skin is injected with anesthetic containing epinephrineuntil anesthesia is achieved. In one embodiment, about a 2 cm incisionis made in the skin generally overlying the midportion of the hyoidbone. In one embodiment, the incision is a vertical incision. In anotherembodiment, the incision is a horizontal incision. The subcutaneoustissue is dissected until the platysma muscle is reached. Skinretractors may used to maximize and maintain the visibility of theexposed incision site. At least a 1 cm vertical midline incision is madein the platysma muscle to expose at least a portion of the hyoid bone.Blunt dissection is then performed along the hyoid bone to each lateralside of the incision site to created a dissected space and to facilitateinsertion of a hyoid brace along the anterior surface of the hyoid bone.In one embodiment, blunt dissection is initiated by curved surgicalforceps. In another embodiment, blunt dissection is performed by acurved blunt dissection instrument having a curvature portion thatgenerally approximates the curvature of the hyoid bone from the midlineto at least the lesser horn, or more. In one embodiment, hemostasis ofthe incision and dissection area is achieved using an electrocauterydevice known to those skilled in the art.

In one embodiment the blunt dissection instrument is used to measure thesize and configuration of the hyoid bone. In another embodiment, theblunt dissection instrument further comprises a distal end with animaging sensor. In one embodiment the size and configuration informationmay be used to select a particular brace appropriate to particularcharacteristics of the hyoid bone to be treated. In another embodimentthe blunt dissection instrument is palpable through the skin to allowthe operator to determine the extent of dissection and to allow theoperator place puncture sites lateral to the initial incision site tofacilitate manipulation of instruments and an attachment of a brace ontothe hyoid bone.

In one embodiment, the hyoid brace is inserted into the dissection spaceand approximately against the surface of the hyoid bone 15. In oneembodiment, the placement of the hyoid brace or brace components areperformed under ultrasound guidance. In one embodiment, the placement ofthe hyoid brace or brace components is performed under fluoroscopy. Inone embodiment, a hyoid brace in the folded position is inserted throughan incision site. After or during the insertion, the hyoid brace thenassumes the unfolded position in approximation along the hyoid bone 15.

In one embodiment, the hyoid brace is inserted manually by hand into thedissected area. In another embodiment, the hyoid brace is inserted intothe dissected area using a delivery member 100.

In another embodiment, brace arms 52 are inserted separately into thedissected space and attached to the hyoid bone 15. A bridge 53 is thenattached to each brace arm 52 and adjusted, if possible, to position thebrace arms 52. The delivery member releases the brace or brace arms.

In another embodiment, the brace arms are inserted into the infrahyoidor suprahyoid musculature adjacent to the hyoid bone. Attachment of thebridge reconfigures the soft tissue about the hyoid bone and dilates orsupports the pharyngeal walls, depending upon the internal bias andflexibility of the brace arms and bridge.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

What is claimed is:
 1. A method of treating a patient, comprising thesteps of: providing a hyoid bone support, the support having a first armand a second arm which are transformable from a moveable relationshipwith respect to each other to a fixed relationship with respect to eachother, wherein the two arms are connected to one another; attaching thefirst arm to a first part of a hyoid bone; attaching the second arm to asecond part of the hyoid bone; changing the configuration of the hyoidbone by moving the two arms while in the moveable relationship withrespect to each other; and securing the support by placing the two armsin the fixed relationship with respect to each other.
 2. A method oftreating a patient as in claim 1, wherein the changing the configurationstep further comprises increasing a lateral distance between the firstand second parts of the hyoid bone.
 3. A method of treating a patient asin claim 1, wherein the changing the configuration step furthercomprises increasing an anterior-posterior distance between the firstand second parts of the hyoid bone.
 4. A method of treating a patient asin claim 3, wherein the increasing the anterior-posterior distance ofthe changing the configuration step further comprises inserting at leastone spacer between the first and second parts of the hyoid bone.
 5. Amethod of treating a patient as in claim 3, wherein the increasing theanterior-posterior distance of the changing the configuration stepfurther comprises attaching a brace to the first and second arms of thehyoid bone support to expand the distance between the first and secondarms of the hyoid bone support.
 6. A method of treating a patient as inclaim 1, wherein the changing the configuration step is accomplishedbefore at least one of the attaching steps.
 7. A method of treating apatient as in claim 1, wherein the changing the configuration step isaccomplished following both of the attaching steps.
 8. A method oftreating a patient as in claim 1, wherein at least one of the attachingsteps further comprises using a bone screw.
 9. A method of treating apatient as in claim 1, wherein at least one of the attaching stepsfurther comprises using a bone clip.
 10. A method of treating a patientas in claim 1, wherein at least one of the attaching steps furthercomprises using a suture.
 11. A method of treating a patient as in claim1, wherein at least one of the attaching steps further comprises usingan adhesive.
 12. A method of treating a patient as in claim 1, whereinat least one of the attaching steps further comprises using a mechanicalinterfit between the hyoid bone and the hyoid bone support.